Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Completed
CT.gov ID
NCT03187418
Collaborator
(none)
52
Enrollment
1
Location
1
Arm
31.9
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: MicroPulse® P3 Glaucoma Device (MP3)
N/A

Detailed Description

Cyclophotocoagulation (CPC) is a type of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. This strategy is effective for all forms of glaucoma.

Traditional trans-scleral cyclophotocoagulation (TSCPC) achieve its cyclodestructive action by using continuous diode laser to target the melanin in the pigmented ciliary body epithelium. However, the continuous mode has been shown to cause significant collateral tissue damage to adjacent non-pigmented structures including the ciliary stroma and ciliary muscle. Traditional TSCPC may therefore be associated with serious complications including uveitis, visual deterioration, chronic hypotony, and others.

More recently, a micropulse delivery mode of diode laser (Micropulse TSCPC, mTSCPC) has been used to treat glaucoma by ablating the ciliary processes and reduce aqueous humor production with more selective targeting and less collateral damage. In contrast to conventional laser delivery where a continuous flow of high intensity energy is delivered, micropulse laser application delivers a series of repetitive short pulses of energy with rest periods in between pulses. Only a few studies have described the outcomes of this novel glaucoma therapy, showing mTSCPC to have comparable efficacy with fewer side effects when compared with traditional continuous wave mode diode laser delivery.This improved side effect profile has the potential to make mTSCPC an earlier therapeutic option instead of reserving it exclusively for end-stage refractory eyes.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, interventional and monocentric study based in a university hospital settingProspective, interventional and monocentric study based in a university hospital setting
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation (mTSCPC) in Uncontrolled Glaucoma at the University of Montreal Hospital Center (CHUM)
Actual Study Start Date :
Jun 19, 2017
Actual Primary Completion Date :
Feb 15, 2020
Actual Study Completion Date :
Feb 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Micropulse trans-scleral CPC

A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).

Device: MicroPulse® P3 Glaucoma Device (MP3)
Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
Other Names:
  • CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)
  • Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure (IOP) [18 months]

      In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

    Secondary Outcome Measures

    1. Intraocular Pressure (IOP) [1 week, 1 month, 3 months, 6 months, 12 months]

      In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

    2. Number of Participants With Repeat Treatments [18 months]

      Number of participants needing a repeat laser treatment during the study

    3. Number of Intraocular Pressure Lowering Medications [1 week, 1 month, 3 months, 6 months, 12 months, 18 months]

      Number of drops and oral medications used by the patient compared to baseline

    4. Corrected Distance Visual Acuity (CDVA) [1 week, 1 month, 3 months, 6 months, 12 months, 18 months]

      Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters

    5. Cup-to-disc Ratio (CDR) [18 months]

      Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination

    6. Visual Field Index (VFI) [18 months]

      Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    7. Mean Deviation (MD) [18 months]

      Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    8. Pattern Standard Deviation (PSD) [18 months]

      Determined by Humphrey automated perimetry Sita 24-2 visual field testing

    9. Average Retinal Nerve Fiber Layer (RNFL) Thickness [18 months]

      In micrometer, determined by optical coherence tomography (OCT)

    10. Average Ganglion Cell Layer (GCL) Thickness [18 months]

      In micrometer, determined by optical coherence tomography (OCT)

    11. Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT) [18 months]

      Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters

    12. Pain Level During Laser Treatment [1 day]

      Using a verbal analog scale for pain level (none = no subjective feeling of pain, mild = pain easily tolerable, moderate = pain tolerable with difficulty, severe = pain intolerable)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients of either sex and any race aged 18 years old and above.

    • Followed by a glaucoma subspecialist at University of Montreal Hospital Center.

    • Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.

    1. mild glaucoma: IOP > 18 mmHg

    2. moderate glaucoma: IOP > 15 mmHg

    3. advanced glaucoma: IOP > 12 mmHg

    • Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.
    Exclusion Criteria:
    • Patients unable to give informed consent.

    • Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.

    • Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.

    • Intraocular surgery in the study eye in the 2 months prior to enrolment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Centre Hospitalier de l'Université de Montréal (CHUM)MontréalQuebecCanadaH2X 3E4

    Sponsors and Collaborators

    • Centre hospitalier de l'Université de Montréal (CHUM)

    Investigators

    • Principal Investigator: Harmanjit Singh, MD, Centre hospitalier de l'Université de Montréal (CHUM)
    • Principal Investigator: Michael Marchand, MD, Centre hospitalier de l'Université de Montréal (CHUM)

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT03187418
    Other Study ID Numbers:
    • CE16.351
    First Posted:
    Jun 15, 2017
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Period Title: Overall Study
    STARTED52
    COMPLETED52
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Overall Participants52
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    69
    (14)
    Sex: Female, Male (Count of Participants)
    Female
    26
    50%
    Male
    26
    50%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    41
    78.8%
    African American
    6
    11.5%
    Middle East
    3
    5.8%
    Asian
    2
    3.8%
    Region of Enrollment (participants) [Number]
    Canada
    52
    100%
    Glaucoma diagnosis (Count of Participants)
    Primary open angle glaucoma
    28
    53.8%
    Neovascular glaucoma
    5
    9.6%
    Pseudoexfoliative glaucoma
    4
    7.7%
    Congenital/infantile glaucoma
    4
    7.7%
    Chronic primary angle-closure glaucoma
    3
    5.8%
    Pigmentary glaucoma
    3
    5.8%
    Other secondary glaucoma
    2
    3.8%
    Uveitic/inflammatory glaucoma
    1
    1.9%
    Combined mechanism glaucoma
    1
    1.9%
    Normotensive glaucoma
    1
    1.9%
    Glaucoma severity (Count of Participants)
    Mild
    1
    1.9%
    Moderate
    16
    30.8%
    Advanced
    35
    67.3%

    Outcome Measures

    1. Primary Outcome
    TitleIntraocular Pressure (IOP)
    DescriptionIn millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [millimeters of mercury (mm Hg)]
    15.2
    (4.1)
    2. Secondary Outcome
    TitleIntraocular Pressure (IOP)
    DescriptionIn millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
    Time Frame1 week, 1 month, 3 months, 6 months, 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    1 week
    18.2
    (6.3)
    1 month
    19.2
    (7.4)
    3 months
    18.6
    (6.2)
    6 months
    17.9
    (5.3)
    12 months
    16.7
    (5.6)
    3. Secondary Outcome
    TitleNumber of Participants With Repeat Treatments
    DescriptionNumber of participants needing a repeat laser treatment during the study
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Count of Participants [Participants]
    10
    19.2%
    4. Secondary Outcome
    TitleNumber of Intraocular Pressure Lowering Medications
    DescriptionNumber of drops and oral medications used by the patient compared to baseline
    Time Frame1 week, 1 month, 3 months, 6 months, 12 months, 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    1 week
    3.5
    (0.7)
    1 month
    3.4
    (0.8)
    3 months
    3.4
    (0.9)
    6 months
    3.4
    (0.8)
    12 months
    3.2
    (0.9)
    18 months
    3.2
    (0.9)
    5. Secondary Outcome
    TitleCorrected Distance Visual Acuity (CDVA)
    DescriptionNumber of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters
    Time Frame1 week, 1 month, 3 months, 6 months, 12 months, 18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    1 week
    0.81
    (0.86)
    1 month
    0.84
    (0.90)
    3 months
    0.79
    (0.88)
    6 months
    0.77
    (0.86)
    12 months
    0.79
    (0.86)
    18 months
    0.82
    (0.88)
    6. Secondary Outcome
    TitleCup-to-disc Ratio (CDR)
    DescriptionProgression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [ratio]
    0.82
    (0.13)
    7. Secondary Outcome
    TitleVisual Field Index (VFI)
    DescriptionDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [percents]
    57
    (27)
    8. Secondary Outcome
    TitleMean Deviation (MD)
    DescriptionDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [decibel (dB)]
    -15.16
    (7.72)
    9. Secondary Outcome
    TitlePattern Standard Deviation (PSD)
    DescriptionDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [decibel (dB)]
    7.87
    (3.18)
    10. Secondary Outcome
    TitleAverage Retinal Nerve Fiber Layer (RNFL) Thickness
    DescriptionIn micrometer, determined by optical coherence tomography (OCT)
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [micrometers]
    62
    (12)
    11. Secondary Outcome
    TitleAverage Ganglion Cell Layer (GCL) Thickness
    DescriptionIn micrometer, determined by optical coherence tomography (OCT)
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [micrometers]
    53
    (14)
    12. Secondary Outcome
    TitleCup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
    DescriptionProgression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters
    Time Frame18 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    Mean (Standard Deviation) [ratio]
    0.82
    (0.13)
    13. Secondary Outcome
    TitlePain Level During Laser Treatment
    DescriptionUsing a verbal analog scale for pain level (none = no subjective feeling of pain, mild = pain easily tolerable, moderate = pain tolerable with difficulty, severe = pain intolerable)
    Time Frame1 day

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    Measure Participants52
    None
    34
    65.4%
    Mild
    12
    23.1%
    Moderate
    6
    11.5%
    Severe
    0
    0%

    Adverse Events

    Time Frame18 months
    Adverse Event Reporting Description All participants completed the study without any adverse events after 18 months of follow-up. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed beyond 18 months.
    Arm/Group TitleMicropulse Trans-scleral CPC
    Arm/Group DescriptionA treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). MicroPulse® P3 Glaucoma Device (MP3): Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).
    All Cause Mortality
    Micropulse Trans-scleral CPC
    Affected / at Risk (%)# Events
    Total0/52 (0%)
    Serious Adverse Events
    Micropulse Trans-scleral CPC
    Affected / at Risk (%)# Events
    Total0/52 (0%)
    Other (Not Including Serious) Adverse Events
    Micropulse Trans-scleral CPC
    Affected / at Risk (%)# Events
    Total0/52 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Michael Marchand, MD
    OrganizationCentre Hospitalier de l'Universite de Montreal (CHUM)
    Phone514-890-8000
    Emailmichael.marchand-gareau@umontreal.ca
    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT03187418
    Other Study ID Numbers:
    • CE16.351
    First Posted:
    Jun 15, 2017
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Aug 1, 2020